A Phase 2 interventional study of LPCN 1144 in NASH - Nonalcoholic Steatohepatitis, sponsored by Lipocine Inc.. Completed at 10 sites in United States. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-07-17.
Sponsored by Lipocine Inc. · Phase 2, Interventional, and Treatment
This is an open-label extension to Study LPCN 1144-18-002. The study is aimed at evaluating the safety and tolerability of LPCN 1144 in adult men with NASH.
This is a multicenter, open-label extension protocol to provide LPCN 1144, an investigational drug, to subjects with NASH who have completed the LPCN 1144-18-002 protocol. Enrolled subjects will be given LPCN 1144 for up to 36 weeks. Subjects will be seen periodically to evaluate safety clinical laboratory tests, tolerability of LPCN 1144, adverse events, and overall subject health. Subjects will be given the option of having a liver biopsy performed at Week 36.
1,617 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 324 are open to participants now.
This study's enrollment of 25 is below the median of 60 across 1,176 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →Lipocine Inc. is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LPCN 1144
Drug: LPCN 1144
Oral LPCN 1144, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose).
Also known as: testosterone undecanoate
Safety and Tolerability of LPCN 1144
Number of subjects presenting with a treatment-emergent adverse events
Time frame: Baseline to Week 36
| Milestone | Treatment A |
|---|---|
| Started | 25 |
| Completed | 23 |
| Not completed | 2 |
Number of subjects presenting with a treatment-emergent adverse events
| Participants | Treatment A |
|---|---|
| Safety and Tolerability of LPCN 1144 | 10 |
Collected over 9 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment A | 1/25 (4%) | 1/25 (4%) | 2/25 (8%) |
| Event | Treatment A |
|---|---|
| Respiratory FailureRespiratory, thoracic and mediastinal disorders | 1/25 |
| Event | Treatment A |
|---|---|
| Upper respiratory infectionInfections and infestations | 2/25 |
Subjects who completed the 38 week study LPCN 1144-18-002 as planned and wanted to continue in this open label extension study
| Age, Continuous(years) | Treatment A |
|---|---|
| Mean | 53.8 ± 8.4 |
| Sex: Female, Male(Participants) | Treatment A |
|---|---|
| Female | 0 |
| Male | 25 |
| Ethnicity (NIH/OMB)(Participants) | Treatment A |
|---|---|
| Hispanic or Latino | 9 |
| Not Hispanic or Latino | 16 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Treatment A |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 24 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Nov 2020 to primary completion in Mar 2022, 15 months.
Results were first posted in Jul 2024, 2 years 4 months after primary completion.
Of 132 industry-sponsored phase 2 interventional studies under Non-alcoholic Fatty Liver Disease, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 30. This study's 15 months is below that.
Counting every sponsor, half of 185 studies reached it within 26 months; a quarter within 16 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Testosterone undecanoate
Non-alcoholic Fatty Liver Disease →
Lipocine Inc.